ABBOTT PARK, Ill., Nov. 12, 2012 /PRNewswire via COMTEX/ --Abbott
(NYSE: ABT) today announced the first long-term patient-reported
health outcomes data from an open-label analysis of the ongoing,
Phase 3 ABILITY-1 trial of HUMIRA® (adalimumab). The study
evaluated improvements in physical function and health-related
quality of life (HRQOL) after 52 weeks in patients with active
non-radiographic axial spondyloarthritis (nr-axSpA). These results
are being presented at the American College of Rheumatology Annual
Scientific Meeting (ACR) in Washington, D.C.

"There are many adults, especially younger, with nr-axSpA whose
disease can be as painful, and have similar adverse impact on the
ability to function, as those with more classic ankylosing
spondylitis," said Professor Philip Mease, University of Washington
and Swedish Medical Center, Seattle, Washington. "This study
evaluated adalimumab treatment on reduction of signs and symptoms
in nr-axSpA patients and the improvement of important
patient-reported outcomes including physical function and
health-related quality of life, goals we all want for this often
inadequately recognized and treated patient group."

Study Results
An exploratory, post-hoc analysis of data from the open-label
extension showed that nr-axSpA patients taking HUMIRA continued to
experience improvement in physical function and HRQOL measures at
week 52. In both the double-blind and open-label phases of the
study, physical function was assessed using the disability index of
the Health Assessment Questionnaire for Spondyloarthropathies
(HAQ-S). Approximately 62 percent of patients met the minimum
important difference (MID) for the HAQ-S of 0.26 at week 52.

The HRQOL was assessed using the Short Form 36 Health Survey
(SF-36) score. 77 percent of patients met the MID for SF-36
Physical Component Summary (PCS) score of 3.0 at week 52. Placebo
patients who switched to open-label HUMIRA experienced improvements
in HRQOL comparable to patients who received HUMIRA through week
52. By week 52, patients in both groups achieved SF-36 scores (42.8
and 44.1, respectively), expressed on a scale of 0-100, where
higher scores indicate better health and well-being.

AxSpA can be a debilitating disease most often seen in younger
individuals in their most productive time of life, and can go
unrecognized for years. AxSpA, which includes ankylosing
spondylitis (AS) and nr-axSpA, primarily presents with chronic back
pain and stiffness, and can be accompanied by the presence of
arthritis, inflammation in the eye and/or gastrointestinal tract.
People with nr-axSpA can have similar signs and symptoms as AS -
including inflammation that can lead to chronic pain and loss of
function - but do not have X-ray evidence of structural damage.

"Patient-reported outcomes data focusing on physical function
and health-related quality of life help measure the impact
treatment has on patients in their day-to-day life," said John R.
Medich, Ph.D., divisional vice president, Immunology Clinical
Development, Global Pharmaceutical Research and Development,
Abbott. "Because there are currently so few treatment options
available to help patients with non-radiographic axSpA, Abbott
remains committed to exploring ways HUMIRA can help improve the
care and outlook for this patient population."

In the open-label extension, both the investigator and patient
knew that patients were receiving HUMIRA. Additionally, open-label
extension data may be enriched as patients who remain in the study
long-term tend to do better than those who drop out. Physical
function and SF-36 PCS were two of nine secondary endpoints
evaluated in the double-blind portion of the study, all of which
were statistically significant for HUMIRA versus placebo.

Additional results from the double-blind period showed that
nr-axSpA patients taking HUMIRA experienced a statistically
significantly greater improvement in HAQ-S as compared to placebo
(-0.3 versus -0.1 respectively; P=0.025.) at week 12, as well as a
statistically significantly greater improvement in SF-36 PCS (5.5
versus 2.0, respectively; p<0.001) at week 12. Patients were
then entered into an open-label period, in which all participants
(n=179) could receive HUMIRA, and were asked to again complete the
health assessment questionnaires at week 52.

In July 2012, the European Commission approved HUMIRA for the
treatment of adults with severe nr-axSpA, making it the first
biologic and only approved medication available for this disease in
Europe. In the U.S., HUMIRA is being investigated for the treatment
of nr-axSpA and is not approved for the treatment of
spondyloarthritides other than AS and psoriatic arthritis.

About SpA
Spondyloarthritis (SpA) is a group of diseases that share common
clinical, radiographic and genetic features. SpA can be categorized
according to which part of the body is mainly affected - axial or
peripheral. Assessment of SpondyloArthritis International Society
(ASAS) developed improved classification criteria for axial and
peripheral SpA designed to facilitate identification and
classification of people with SpA who share similar symptoms.
Criteria for axial SpA incorporate the use of magnetic resonance
imaging (MRI), in addition to traditional X-rays, for visualizing
sacroiliitis (inflammation of the sacroiliac joint which connects
the lower spine and pelvis), one of the hallmarks of axial
spondyloarthritis. While worldwide epidemiologic data does not
exist for axSpA, studies have shown it is estimated that axSpA
affects up to 1 percent of adults in the United States.

About ABILITY-1
ABILITY-1 is the first large, pivotal study to use the ASAS
criteria to classify nr-axSpA patients, and to evaluate an
anti-tumor necrosis factor medication (anti-TNF) in treating
patients with nr-axSpA. It is an ongoing, multi-country, Phase 3
study designed to evaluate the efficacy and safety of HUMIRA in
nr-axSpA patients.

Eligible patients were randomized 1:1 to receive either HUMIRA
(40 mg every other week, n=91) or placebo (n=94) for 12 weeks. The
primary endpoint results from this double-blind, placebo-controlled
study showed that a significantly higher percentage of HUMIRA
patients, compared to those receiving placebo, achieved ASAS 40 at
week 12 (36.3 percent versus 14.9 percent; p<0.001). ASAS 40 is
defined as at least a 40 percent improvement from baseline in the
Assessment of SpondyloArthritis International Society (ASAS)
response criteria.

The double-blind period was followed by the open-label extension
phase in which all patients could receive HUMIRA (40 mg every other
week) for up to an additional 144 weeks (n=179). During the
open-label extension phase of the study, both the investigator and
the patient knew that the patient was receiving HUMIRA. Baseline
demographics and disease characteristics were comparable between
patients who entered the open-label period and those of patients
who were initially randomized.

About HUMIRA® (adalimumab)

Uses
HUMIRA (adalimumab) is a prescription used to reduce the signs and
symptoms of ankylosing spondylitis in adults.

HUMIRA is used alone or with certain other medicines to reduce
the signs and symptoms of psoriatic arthritis in adults. It may
prevent further damage to bones and joints and may help with the
ability to perform daily activities.

Important Safety Information
HUMIRA is a TNF blocker medicine that affects the immune system and
can lower the ability to fight infections. Serious infections have
happened in people taking HUMIRA. These serious infections include
tuberculosis (TB) and infections caused by viruses, fungi, or
bacteria that have spread throughout the body. Some people have
died from these infections. People should be tested for TB before
HUMIRA use and monitored for signs and symptoms of TB during
therapy. People at risk of TB may be treated with medicine for TB.
Treatment with HUMIRA should not be started in a person with an
active infection, unless approved by a doctor. HUMIRA should be
stopped if a person develops a serious infection. People should
tell their doctor if they live in or have been to a region where
certain fungal infections are common, have had TB, hepatitis B, are
prone to infections, or have symptoms such as fever, fatigue,
cough, or sores.

For people taking TNF blockers, including HUMIRA, the chance of
getting lymphoma or other cancers may increase. Some people have
developed a rare type of cancer called hepatosplenic T-cell
lymphoma. This type of cancer often results in death. If using TNF
blockers including HUMIRA, the chance of getting two types of skin
cancer (basal cell and squamous cell) may increase. These types are
generally not life threatening if treated.

Other possible serious side effects with HUMIRA include
hepatitis B infection in carriers of the virus, allergic reactions,
nervous system problems, blood problems, certain immune reactions,
including a lupus-like syndrome, liver problems, and new or
worsening heart failure or psoriasis. The use of HUMIRA with
anakinra or abatacept is not recommended. People using HUMIRA
should not receive live vaccines.

The benefits and risks of HUMIRA should be carefully considered
before starting therapy.

This is not a complete list of the Important Safety Information
for HUMIRA. For additional important safety information, please
click for the Full Prescribing Information and Medication
Guide.

About Abbott
Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of
pharmaceuticals and medical products, including nutritionals,
devices and diagnostics. The company employs approximately 91,000
people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on
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